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University of Michigan
Guidelines for
Health System
Clinical Care
Gastroesophageal Reflux Disease (GERD)
Patient population: Adults
Guideline Team
Objective: To implement a cost-effective and evidence-based strategy for the diagnosis and
Team Leader
treatment of gastroesophageal reflux disease (GERD). Joel J Heidelbaugh, MD Family Medicine Key Points:
Team Members
„ Diagnosis
History. A well-taken history is essential in establishing a diagnosis of GERD. If the classic
symptoms of heartburn and acid regurgitation clearly dominate a patient’s history, they can help establish the diagnosis of GERD with sufficiently high specificity, although sensitivity of clinical history remains low compared to 24-hour pH monitoring. The presence of atypical symptoms (Table 1), although common, cannot sufficiently support the clinical diagnosis of GERD. [B*] Testing. No gold standard exists for the diagnosis of GERD [A*]. Although pH probe is accepted
as the standard with a sensitivity of 85% and specificity of 95%, false positives and false negatives still exist [B*]. Endoscopy lacks sensitivity in determining pathologic reflux. Barium radiology has limited usefulness in the diagnosis of GERD and is not recommended [B*]. Therapeutic trial. An empiric trial of acid suppression therapy can identify patients with GERD
who do not have alarm symptoms [A*] and may be helpful in the evaluation of those with atypical manifestations of GERD, specifically, non-cardiac chest pain (NCCP) [B*]. UMHS Guidelines
„ Treatment
Oversight Team
Lifestyle modifications. Lifestyle modifications should be recommended throughout the treatment
of GERD, but there is little evidence-based data to support their efficacy [D*]. William E Chavey, MD R Van Harrison, PhD Pharmacologic treatment. H2-receptor antagonists (H2RAs), proton pump inhibitors (PPIs), and
prokinetics have proven efficacy in the treatment of GERD [A*]. Past prokinetics have been as effective as H2RAs but are currently unavailable [A*]. Carafate and antacids are ineffective [A*], but may be used as supplemental acid-neutralizing agents for certain patients with GERD [D*]. • Non-erosive reflux disease (NERD): Step-up (H2RAs followed by a PPI if no improvement) and Literature search service
step-down (PPI followed by the lowest dose of acid suppression) therapy are equally effective for both acute treatment and maintenance [C*]. Costs for step-down treatment are mainly medications, while step-up treatment requires more frequent endoscopy. On demand (patient- directed) therapy is the most cost-effective strategy. • Documented erosive esophagitis: Initial PPI therapy is the treatment of choice for acute and For more information call GUIDES: 734-936-9771 maintenance therapy for patients with documented erosive esophagitis [A*]. • PPI’s should be taken 30-60 minutes prior to a meal to optimize effectiveness [B*]. Surgery. Antireflux surgery is an alternative modality in the treatment of GERD in patients who
have documented chronic reflux with recalcitrant symptoms [A*]. Surgery has a significant Regents of the
complication rate (10-20%). Resumption of pre-operative medication treatment (>50%) is common University of Michigan
Other endoscopic modalities. Some alternative endoscopic modalities are less invasive and have
fewer complications, but are also likely to have lower response rates than antireflux surgery [C*], and have not been shown to reduce acid exposure. „ Follow up
Symptoms unchanged. If symptoms remain unchanged in a patient with a prior normal
endoscopy, repeating endoscopy has no benefit and is not recommended [C*]. construed as including all proper methods of care or Warning signs. Patients with warning signs and symptoms suggesting complications from GERD
(Table 2) should be referred to a GERD specialist. methods of care reasonably directed to obtaining the same Risk for complications. Further diagnostic testing (e.g., EGD [esophagogastroduodenoscopy], pH
monitoring) should be considered in patients who do not respond to acid suppression therapy [C*] regarding any specific clinical procedure or treatment must be and in patients with a chronic history of GERD who are at risk for complications (e.g., Barrett’s esophagus, adenocarcinoma, stricture). Chronic reflux has been suspected to play a major role in of the circumstances presented by the patient. the development of Barrett’s esophagus, yet it is unknown if outcomes can be improved through surveillance and medical treatment [D*]. Costs of surveillance for Barrett’s Esophagus without dysplasia are likely to be prohibitive [B*]. Anti-reflux therapy has been shown to reduce the need for recurrent dilation from esophageal stricture formation [A*]. * Levels of evidence reflect the best available literature in support of an intervention or test:
A=randomized controlled trials; B=controlled trials, no randomization; C=observational trials; D=opinion of expert panel.
Figure 1. Diagnosis and Treatment of GERD
Table 1. Atypical
Table 2. Warning Signs
Table 3. Lifestyle Modifications [D*]
Signs of GERD
Suggesting Complicated GERD
Avoid recumbency for 3 hours postprandially Avoid certain foods: chocolate, alcohol, peppermint, coffee, onions, garlic, fatty foods, citrus, tomato Avoid medications that can potentiate symptoms Table 4. Medications for Acute Treatment and Maintenance Regimens
Drug Dose Dosage $
Cost/Month
Equivalents
Brand Generic
20 mg daily/40 mg daily/40 mg BID 142/142/284 40 mg daily/80 mg daily/40 mg BID 114/228/228 30 mg daily/60 mg daily/30 mg BID 144/288/288 a For brand drugs, Average Wholesale Price minus 10%. AWP from Amerisource Bergen Wholesale Catalog 10/06. For generic drugs, Maximum Allowable Cost plus $3 from BCBS of Michigan MAC List, 8/8/06.
Clinical Background
Clinical Problem
Treatment Decision Problems
Incidence
Although symptomatic relief generally occurs with empiric treatment, the long-term effects of anti-reflux medications Gastroesophageal reflux disease (GERD) is a common are as yet unknown. Complications from GERD (e.g., chronic, relapsing condition that carries a risk of significant Barrett’s esophagus, adenocarcinoma) are rare but do exist; 10-15% with GERD will develop Barrett’s esophagus, and complications. While many patients self-diagnose, self- 5-10% of those with Barrett’s will develop adenocarcinoma treat and do not seek medical attention for their symptoms, over 10-20 years. Chronic reflux has been suspected to others suffer from more severe disease with esophageal play a major role in the development of Barrett’s esophagus damage ranging from erosive to ulcerative esophagitis. (specialized columnar epithelium/intestinal metaplasia), yet it is unknown if outcomes can be improved through More than 60 million adult Americans suffer from surveillance and medical treatment. Anti-reflux therapy has heartburn at least once a month and over 25 million been shown to reduce the need for recurrent dilation from experience heartburn daily. The National Ambulatory Medical Care Survey (NAMCS) found that 38.53 million annual adult outpatient visits were related to GERD. For Previous cost-effectiveness models were flawed in that patients presenting with GERD symptoms, 40-60% or more certain studies examined only patients with erosive have reflux esophagitis. Up to 10% of these patients will esophagitis and excluded patients with non-erosive have erosive esophagitis after investigation. GERD appears esophagitis (NERD), while some studies included data on to be more prevalent in pregnant women and a higher anti-reflux surgery only for patients who failed medical complication rate exists among the elderly. Patients with therapy. These studies also viewed a short-term analysis of GERD generally report decreases in productivity, quality of therapeutic efficacy, rather than following patients over a life and overall well-being. Many patients rate their quality lifetime, and did not allow for the switching from one of life to be lower than that reported by patients with untreated angina pectoris or chronic heart failure. GERD is a risk factor for the development of adenocarcinoma, Rationale for Recommendations
further increasing the importance of its diagnosis and Etiology
Extraesophageal manifestations associated with GERD Most patients with GERD have normal baseline LES (lower occur in up to 50% of patients with non-cardiac chest pain, esophageal sphincter) tone. The most common mechanism 78% of patients with chronic hoarseness, and 82% of for acid reflux is transient relaxation of the lower patients with asthma. Over 50% of patients with GERD esophageal sphincter (> 90% of reflux episodes in normal have no endoscopic evidence of disease. Although subjects and 75% of episodes in patients with symptomatic diagnostic limitations occur less often when patients present GERD). Other mechanisms include breaching the LES with the classic symptoms of heartburn and acid because of increased intra-abdominal pressure (strain regurgitation, diagnosis may be difficult in patients with induced reflux) and a baseline low LES pressure. The latter recalcitrant courses and extraesophageal manifestations of two mechanisms increase in frequency with greater reflux severity. Other factors include delayed gastric emptying (co-factor in 20% of GERD patients), medication use Diagnostic Problems
(particularly calcium channel blockers), hiatal hernia (increased strain induced reflux and poor acid clearance The lack of a gold standard in the diagnosis of GERD from hernia sac), and poor esophageal acid clearance presents a clinical dilemma in treating patients with reflux (esophageal dysmotility, scleroderma, decreased salivary symptomatology. Many related syndromes including atypical GERD, H. pylori-induced gastritis, gastroduodenal ulcer and gastric cancer may present similarly, making Natural History
accurate history taking important. Even in these cases the pre-test sensitivity and specificity for accurate diagnosis Most GERD patients do not seek medical attention (80- remain low. Invasive testing is over-utilized and not always 90%) and self-medicate (50%). In patients seeing cost-effective, given the relatively small risk of physicians, most will have chronic symptoms that will misdiagnosis based upon an accurate patient history. occur off treatment. Patients with more severe esophagitis Empiric pharmacotherapy is advantageous based on both will have symptoms recur more quickly and almost all will have recurrent symptoms and esophagitis if followed up for > 1 year. Progression of disease can be seen in up to 25% of patients with esophagitis, but it is less likely to occur if esophagitis is not present or is mild (LA class A, B). Empiric therapy should be tried for two weeks for patients Complications such as Barrett’s esophagus, esophageal with typical GERD symptoms. Treatment can be initiated ulcers, esophageal stricture or adenocarcinoma of the with standard dosage of either an H2RA BID (on demand) esophagus are very rare unless the initial endoscopy shows or a PPI (30-60 minutes prior to first meal of the day), with esophagitis or Barrett’s esophagus. A normal endoscopy drug selection depending on clinical presentation and with symptomatic GERD presents a good prognosis. Long appropriate cost effectiveness and the end point of complete term natural history studies are few and are urgently symptom relief. (See Figure 1 and Table 4). If symptom relief is not adequate and H2RA BID was initially used, then PPI daily should be used. If PPI daily was initially Diagnosis
used, then increase to maximum dose PPI daily or BID (30- 60 minutes prior to first and last meals). Evidence-based limitations exist when trying to assess the validity of the diagnostic modalities for GERD. Most For those patients who initially present with more severe studies are flawed methodologically because no gold and more frequent symptoms of typical GERD, treatment standard exists. However, the calculated numbers are may be initiated with higher and more frequent dosages of helpful in providing a framework to assess available an H2RA or PPI. If symptom relief is not adequate from options. Recent studies suggests that combining diagnostic initial dose, then increase potency/frequency as needed to modalities (omeprazole challenge test, pH monitoring, and obtain complete symptom relief: high-dose H2RA to PPI endoscopy) may increase the sensitivity for diagnosis of daily, PPI daily or maximum dose PPI daily or BID. If GERD (approaching 100%), but this approach is not there is no response when using higher dosages, then practical in the routine clinical setting. diagnostic testing should be performed. If patient responds, give 8-12 weeks of therapy, i.e. enough to heal undiagnosed History. A well-taken history is essential in establishing
esophagitis. If patient has complete symptom relief at 8-12 the diagnosis of GERD. Symptoms of classic burning in weeks, taper over 1 month to lowest effective dose of the the chest, with sour or bitter taste, and acid regurgitation medication that gives complete relief, e.g., H2RA on have been shown to correctly identify GERD with a demand, PPI QOD. If symptoms reoccur, put patient back sensitivity of 89% and specificity of 94%. However, on initial effective medication and dose, and consider symptom frequency, duration and severity are equally further testing depending on clinical presentation and distributed among patients with varying grades of esophagitis and Barrett’s esophagus and cannot be used reliably to diagnose complications of GERD. Patients who present with atypical or extraesophageal manifestations take a longer time to respond to empiric PPI diagnostic test. A response to a short course of
therapy. If there is no improvement at all in symptoms after proton-pump inhibitors (PPIs) is commonly considered to one month, further testing should be pursued. support a diagnosis of GERD. PPIs have been studied and
tried more often than H2-receptor antagonists given their Endoscopy. Endoscopy is the primary technique for
higher efficacy. A recent meta-analysis found that a evaluating mucosal integrity, esophageal stricture successful short-term trial of PPI therapy did not formation, and Barrett's esophagus with a sensitivity of confidently establish a diagnosis of GERD (sensitivity 78%, 50% and specificity of 95%. Endoscopic evidence of specificity 54%) when 24 hour pH monitoring was used as esophagitis occurs in less than 50% of people who have the reference standard. This may be due to observed experienced heartburn greater than twice a week over a six- clinical benefit of PPIs in treating other acid-related conditions (as seen in the heterogeneous dyspeptic population), patients with enhanced esophageal sensitivity Esophagitis is best defined by the LA classification system to acid (without true GERD), or even due to a placebo and identifies the degree to which mucosal breaks (erosions effect. In those with NCCP (non-cardiac chest pain), or ulcerations) occur, graded in severity from A to D, with empiric trial with high-dose omeprazole (40 mg AM, 20 mg D being the most severe. Specific definitions are: PM) had a sensitivity of 78% and specificity of 85%. A One or more mucosal breaks no longer than 5 mm, Standard dosages may have lower sensitivity and none of which extends between the tops of the B One or more mucosal breaks more than 5 mm long, Empiric/therapeutic trial. Diagnostic modalities cannot
none of which extends beyond the tops of two reliably exclude GERD even if they are negative. Therefore an empiric trial may be the most expeditious way C Mucosal breaks that extend between the tops of two in which to diagnose GERD in those with classic symptoms or more mucosal folds, but which involves less than and who do not have symptoms suggestive of complications (e.g., carcinoma, stricture). (Also see the discussion of D Mucosal breaks which involve at least 75% of the "step-up" therapy and "step-down" therapy in treatment (Dent, J et al. An evidence-based appraisal of reflux symptoms with reflux events. Associations greater than disease management-the Genval Workshop Report. Gut The purpose for pH probe must be defined before Although biopsy is indicated in defining Barrett's proceeding: is it to diagnose GERD or to determine the esophagus, histological assessment has not been clinically adequacy of therapy. The test should be performed off useful in the diagnosis of GERD if endoscopy is positive therapy if the diagnosis is under question. The test should for mucosal abnormalities. Descriptives such as erythema, be performed on therapy if one is trying to determine the edema, and friability also are not clear indications of adequacy of treatment. The major indication for performing 24 ambulatory pH monitoring is in documenting treatment failures, either to antireflux surgery Endoscopy should be considered in those who present with warning symptoms (see Table 2) and who are suspected to have complications from GERD. Further testing should Other diagnostic modalities. Other diagnostic modalities
also occur for patients who do not respond to therapy, need include manometry, Bernstein’s test and gastroesophageal continuous chronic therapy and have risk factors for scintigraphy. Due to their many limitations, these tests should not be routinely ordered. Barium swallow should not be used in the evaluation of GERD although it was Repeating endoscopy is likely not to be worthwhile commonly used in the past. It is useful in the evaluation of following a normal result. In observational studies, patients dysphagia but limited in its ability as a screening test for with an initial normal endoscopy have not been found to GERD, as are all the aforementioned modalities. progress to severe esophagitis during a 10 year follow-up, thus arguing against repeat endoscopy in a select group of patients whose symptom complex has not changed during Treatment
this time. However, some patients did progress to grade A Lifestyle modifications. For a history typical for
uncomplicated GERD, expert opinion is to discuss and
PH probe. Many patients do not have evidence of
offer various lifestyle modifications throughout the course
esophagitis on endoscopy and yet they respond to acid of GERD therapy (see Table 3). Neither the efficacy nor suppression and have behaviors and concerns that parallel the potential negative effects of lifestyle changes on a those who have evidence of mucosal damage. Patients with patient’s quality of life have been adequately examined for endoscopic-negative GERD and who do not respond to any of these modifications. With relatively little data medications are best evaluated by ambulatory pH available, it is reasonable to educate patients about factors monitoring. On average, patients with endoscopic-negative reflux have less acid exposure than those with esophagitis, but more compared to people without reflux. However, Head elevation. Numerous studies have indicated that normal acid exposure has been found in up to 29% of the elevation of the head of a patient’s bed by 4 to 8 inches, patients with documented reflux esophagitis and in up to as well as avoiding recumbency for 3 hours or greater after 33% of patients with endoscopic-negative GERD. a large or fatty meal, may decrease distal esophageal acid exposure. However, data reflecting the true efficacy of this Ambulatory pH monitoring is based upon the amount of maneuver in patients is almost completely lacking. It has time the intraesophageal pH is less than 4, with normal also been suggested that patients should avoid sleeping on defined as less than 4% over a 24-hour period. Patients are additional pillows, as this may increase abdominal pressure expected to perform their usual activities with dietary and lifestyle restrictions minimized in order to improve the Avoid certain foods. Several foods are believed to be direct esophageal irritants: citrus juices, carbonated Recent advances in “wireless” pH radiotelemetry capsule beverages, coffee and caffeine, chocolate, spicy foods, fatty technology eliminates the need for the uncomfortable foods, or late evening meals. However, no randomized nasoesophageal tube, and increases diagnostic yield by controlled trials to support recommendations to avoid or allowing for longer monitoring (e.g., now 48-hour and soon minimize these foods. Individualized dietary modification 96-hour). Also, intraluminal impedance monitoring can detect “nonacid” (i.e. liquid/gas) reflux, which may be important in medically refractory patients with regurgitation Weight loss. An association among weight, reflux and who are being considered for surgery or in patients with reflux complications has been demonstrated. Weight loss atypical symptoms. Correlating symptoms with reflux has been shown to improve global symptom scores, events is important in those with EGD-negative GERD and particularly if weight gain occurred before the onset of is helpful in the evaluation of those with extraesophageal or sporadic symptoms. The symptom index associates Smoking cessation and alcohol minimization. maximal therapy, the disadvantages include cost, which Smoking cessation and the elimination or minimization of may exceed or equal the cost of a proton-pump inhibitor, as alcohol are also encouraged for a variety of health reasons. Both nicotine and alcohol have been shown to lower LES pressure and lead to further esophageal irritation. A recent No randomized controlled trials exist to examine the course systematic review found that smoking was associated with of incompletely treated GERD, nor are good data available an increase in GERD symptoms (over 1-2 days), yet on the natural history of inflammatory esophageal disease. smoking cessation was not shown to decrease GERD Little information is available on the level of gastric acid symptoms in 3 low-quality studies. Alcohol use may or suppression that is needed to ensure adequate esophageal may not be associated with reflux symptoms. Avoid medications that lower LES pressure. Patients seem to develop some tolerance to the H2RAs, Medications that lower LES pressure should be avoided in with some decreased efficacy observed after 30 days of patients with symptoms of GERD. These medications include calcium channel blockers, β-agonists, α-adrenergic agonists, theophylline, nitrates, and some sedatives. In the short term, randomized controlled trials with patients on placebo found similar rates of adverse effects as Avoid tight clothing around waist. Another anecdotal compared to the RCTs with patients on H2RAs. Most suggestion is that patients refrain from wearing tight evidence describing adverse effects is from case reports or clothing around the waist to minimize strain-induced reflux. uncontrolled trials. H2RAs have been associated with rare cytopenias, gynecomastia, liver function test abnormalities, Over-the-counter (OTC) remedies. Antacids and OTC
and hypersensitivity reactions. In the long-term, no acid suppressants are appropriate, initial patient-directed controlled trials with follow-up on the safety of chronic use therapy for GERD. Antacids (Tums, Rolaids, Maalox) and combined antacid/alginic acid (Gaviscon) have been shown to be more effective than placebo in the relief of daytime Proton Pump Inhibitors (PPIs). Solid evidence from
GERD symptoms. Two long-term studies suggest that numerous randomized controlled trials has shown that PPIs approximately 20% of patients experience some relief from are more effective than both H2RAs and placebo in controlling symptoms from erosive reflux disease (83% compared to 60% and 27%, respectively) over a 4 to 8 week All four of the histamine type-2 receptors antagonists period. One systematic review compared the efficacy of (H2RAs: cimetidine, famotidine, nizatidine, and ranitidine) PPIs and H2RAs and found that a greater number of people have been approved for use in the US as OTC preparations improved symptomatically with PPIs, yet the difference at a dose that is uniformly one-half of the standard lowest was not significant for heartburn remission. One RCT prescription dosage for each compound; ranitidine is now showed that at 12 months, significantly more people were available in an OTC formulation at standard dose. At these still in remission with omeprazole compared to ranitidine. dosages, the H2RAs decrease gastric acid production, Another RCT found that treatment with omeprazole was particularly in the postprandial state, without affecting more likely than ranitidine to improve symptom and esophagogastric barrier dysfunction. The four compounds are virtually interchangeable at these dosages, with similarities in the rapidity and duration of action. The OTC In the treatment of erosive esophagitis, PPIs had faster costs are equivalent (although the generic costs differ by healing rates than either H2RAs or placebo (78% compared dosage). Some patients may predict when they will suffer to 50% and 24%, respectively) over a 4-8 week period. No reflux symptomatology and may benefit from pre- RCTs have examined therapy for a longer period of time. medication with these OTC H2RAs. The OTC H2RAs are believed to be superior in efficacy when compared to One RCT found no evidence of a significant difference among the PPIs, including omeprazole, lansoprazole, rabeprazole and pantoprazole in the healing of erosive H2 antagonists (H2RAs). Numerous randomized,
esophagitis. Efficacy in pH changes was not studied. The controlled trials have demonstrated that standard least expensive PPI is omeprazole, which is available prescription dose H2RAs are more effective than placebo at generically and OTC. A single study showed that relieving heartburn in cases of GERD, with symptomatic esomeprazole, the S-isomer of omeprazole, at doses of 20 relief reported in 60% of cases. A systematic review found mg and 40 mg is more effective than omeprazole 20 mg in that people in trials on H2RAs had faster healing rates than healing and symptom resolution in GERD patients with people in trials on placebo: over a 4-8 week period a healed reflux esophagitis, with a tolerability profile comparable to esophagitis rate of 50% on H2RA and 24% on placebo. that of omeprazole. A recent randomized controlled trial compared esomeprazole 40 mg to lansoprazole 30 mg. Both higher doses and more frequent dosing of H2RAs Esomeprazole was superior in healing and symptom appear to be more effective in the treatment of reflux control, with superiority highest in more severe degrees of symptoms and healing of esophagitis. If the patient is on Newer endoscopic treatments. Radiofrequency heating of
The potential benefit of chronic PPI therapy in patients with the GE junction (Stretta) and endoscopic gastroplasty chronic or complicated GERD generally outweighs any (Bard, Wilson Cook), polymer injections to bolster the GE theoretical risk of adverse events. Decreased cobalamin junction, and full thickness gastroplication have all been absorption has been found, although a clinically significant shown to improve symptoms and quality of life scores in decrease in serum vitamin B12 levels is not usually seen. sham controlled trials. None of these techniques have PPIs cause a profound decrease in gastric acid secretion, consistently reduced acid exposure. Polymer injections which leads to an increase in gastrin production from the have been removed for safety concerns. Durability of antral G-cells. No cases of gastric cancer/carcinoid linked response for all of these modalities (30-50% at 3 years) may to use of the PPIs have been reported since the advent of limit long term usefulness. Complications are relatively this class of medication over 20 years ago. PPIs have been rare in experienced hands and are less than with standard associated with rare community-acquired pneumonia, Clostridium difficile colilis, and hip fracture. Treatment Failure
Several studies have demonstrated that on-demand therapy with PPIs is the most cost-effective method for NERD Empiric trials should be limited if no response is seen. Treatment response should be present in 2-4 weeks for patients with typical symptoms. Patients with atypical Surgical treatment. Anti-reflux surgery is an accepted
symptoms also have an initial response in one month, but alternative treatment for symptomatic acid/bile reflux. The may require 3-6 months for maximal response. Patients basic tenets of surgery are reduction of the hiatal hernia, with atypical symptoms may require higher PPI doses for repair of the diaphragmatic hiatus, strengthening the response. Empiric treatment in patients with atypical gastroesophageal junction-posterior diaphragm attachment, symptoms is appropriate if typical symptoms are also and strengthening the anti-reflux barrier by adding a gastric present. Esophageal pH monitoring off of anti-reflux wrap around the gastroesophageal junction medications might be the best approach initially in patients (fundoplication). Open and laparoscopic surgical repairs with atypical symptoms only since <30% of patients will are available. Controlled trials comparing open and have GERD associated symptoms. If patients with atypical laparoscopic approaches have shown similar efficacy and symptoms do not respond to treatment in 1-3 months, then complications with lower morbidity and shorter hospital GERD is not likely the cause and the other diagnoses Post-surgical complications are common, but typically short Maintenance Regimens
term and manageable in most instances. Short term solid food dysphagia occurs in 10% of patients (2-3% have The goal of maintenance therapy is to have a symptom free permanent symptoms) and gas bloating occurs in 7-10% of individual with no esophagitis. Multiple regimens are used patients. Diarrhea, nausea and early satiety occur more to accomplish this. Increasing severity of esophagitis is rarely. While some complication occurs in up to 20% of associated with increasing need for potent acid reduction patients, major complications occur in only 3-4% of patients. Patient satisfaction is high when GERD Since most individuals with GERD do not undergo endoscopy, chronic acid suppression is tailored to the Controlled trials comparing anti-reflux surgery to antacids, individual. Options include: step-up therapy (starting less H2 receptor antagonists and proton pump inhibitors have potent agents and moving up for treatment response), step- shown marginal superiority to surgery. Recent studies down therapy (using potent acid suppression initially with comparing surgery with proton pump inhibitors have shown decreasing dose or less potent agents to tailor to the similar efficacy if PPI could be titrated to response. Long- individuals response), on demand (patient-directed) term follow-up trials have shown that 52% of patients are therapy, or surgery, All options have the goal of complete back on anti-reflux medications 3-5 years after surgery, most likely secondary to a combination of poor patient Step-up therapy. When beginning step-up therapy, no
more than 2 weeks is needed to determine if a dosage of The choice to consider anti-reflux surgery must be medication will be effective. If a patient does not respond individualized. Patients should have documented acid to an H2 receptor antagonist within 2 weeks, the patient reflux, a defective anti-reflux barrier in the absence of poor should be switched to a proton pump inhibitor, again gastric emptying, normal esophagus motility and at least a emphasizing it be used 30 minutes to 1 hour prior to meals partial response to acid reduction therapy. Surgery appears so that the PPI has time to interact with an activated pump. to be most effective for heartburn and regurgitation (75- 90%) and less effective for extraesophageal symptoms (50- If the patient does not respond to this program, a double- dose program (BID; 30 minutes before breakfast and 30 minutes before dinner) may be effective in reducing symptoms. If the patient does not respond to this program, bronchospasm/asthma). Laryngeal neuropathy has been the patient is likely not to have reflux as a source of their implicated recently as a cause for laryngitis symptoms and symptoms and diagnostic testing would be appropriate. Approximately 40% of patients requiring PPI therapy will Pulmonary. Asthma and GERD are common conditions
need increasing dosage over time. Tolerance to H2 receptor that often coexist with 50-80% of asthmatics having GERD antagonists occurs over time. The main goal is to use the and up to 75% having abnormal pH testing. However, only lowest dose and least potent medication to obtain a 30% of patients who have both GERD and asthma will have complete and sustained symptomatic response. GERD as the cause for their asthma. The causal relationship between asthma and GERD is difficult to Break through symptoms are common and the patients can establish because either condition can induce the other use antacids and/or nocturnal H2 receptor antagonists. (GERD causing asthma as above, and asthma causing These should be limited to individuals who are not getting increased reflux by creating negative intrathoracic pressure symptomatic response, yet have defined reflux as their and overcoming LES barrier). Furthermore, medications source of symptoms. This would be a very small number of used for asthma, such as bronchodilators, are associated patients. H2 receptor antagonists should not be with increased reflux symptomatology. Historical clues to GERD-related asthma may include asthma symptoms that worsen with big meals, alcohol, and supine position, or Step-down therapy. Once symptoms are controlled after
adult-onset and medically refractory asthma. Diagnostic step-up therapy, step-down therapy commences with the testing with pH probe and EGD have limited utility in patient taking a PPI for 8 weeks, followed by an H2RA if establishing causality in this population. GERD symptoms were adequately controlled with a PPI, then stepping down further to on-demand use of antacids if Ear, nose, and throat. In patients presenting with ENT
the patient was asymptomatic while taking an H2RA. The symptoms, 10% of hoarseness, up to 60% of chronic majority of patients who take more than a single daily dose laryngitis and refractory sore throat, and 25-50% of globus of a PPI and who experience relief of symptoms can be sensation may be due to reflux. EGD and pH testing are successfully stepped down to single-dose therapy without a frequently normal in this population. Reflux laryngitis is recurrence of reflux symptoms. However, a small usually diagnosed based on the laryngoscopic findings of percentage of patients with refractory GERD will need laryngeal erythema and edema, posterior pharyngeal long-term therapy with higher doses of a PPI to control coblestoning, contact ulcers, granulomas, and interarytenoid changes. However, a recent study found these signs to be nonspecific for GERD, noting at least 1 sign in 91 of 105 On demand therapy. Treatment can be initiated with
(87%) healthy people without reflux or laryngeal standard dosage of either a PPI daily or an H2RA twice complaints. Many of these signs may be due to other daily on demand (patient directed therapy). Drug selection laryngeal irritants such as alcohol, smoking, postnasal drip, depends on clinical presentation, cost-effectiveness, and viral illness, voice overuse, or environmental allergens, end point of appropriate symptom relief. suggesting their use may contribute to overdiagnosis of GERD. This also may explain why many patients (up to Special Circumstances
40-50%) with laryngeal signs don’t respond to aggressive acid therapy. Posterior laryngitis, medial erythema of Older Adults
false/true vocal cords and contact changes (ulcers and granulomas) are more common in GERD patients and predict a better response to acid reduction. In a patient over the age of 50, new onset of GERD is an alarm sign and endoscopy should be the initial diagnostic Treatment. Aggressive acid reduction using PPIs BID
examination. If reflux is still considered the major cause before meals for at least 2-3 months is now considered the after negative endoscopy, empiric therapy would then be standard treatment for atypical GERD and may be the best way to demonstrate a causal relationship between GERD and extraesophageal symptoms. Recent double blind, Atypical Manifestations of GERD
placebo controlled trials have not shown significant benefit for PPI BID treatment for laryngeal symptoms. Similar As noted in Table 1, GERD may manifest atypically as trials in asthma have shown marginal benefits in FEV pulmonary (asthma, chronic cough), ENT (laryngitis, only when nocturnal GERD symptoms are also present. hoarseness, sore throat, globus, throat clearing) or cardiac Both groups of studies demonstrate the need for better (chest pain) symptoms, often without symptoms of parameters for patient selection. Anti-reflux surgery aimed heartburn and regurgitation. Mechanisms for this include at controlling asthma through prevention of GERD has a direct contact and microaspiration of small amounts of lower rate of success than anti-reflux surgery aimed at noxious gastric contents into the larynx and upper bronchial treating heartburn (45-50% vs. 80-90% respectively). tree (triggering local irritation, and cough), and acid stimulation of vagal afferent neurons in the distal esophagus (causing non-cardiac chest pain and vagally-mediated A systematic review on chronic cough found there is Controversial Areas
insufficient evidence to definitely conclude that PPI treatment is beneficial for cough associated with GERD in Screening for Barrett's Esophagus
adults, although a small beneficial effect was seen in GERD is the major cause for esophageal adenocarcinoma (68-90%). Adenocarcinoma is more common (30-60x) in patients with GERD and increases with increased frequency, severity and duration of reflux symptoms. Initial screening is appropriate especially in Caucasian
males over age 50 and in patients with reflux symptoms for
more than 10 years. If Barrett’s esophagus and/or
esophagitis is not found on initial endoscopy, repeat
surveillance is not indicated unless the patient has a major
change in symptoms.
Surveillance of known Barrett’s esophagus is controversial
because adenocarcinoma of the esophagus is rare in the US
(6000-7000 cases/yr) and GERD/Barrett's occur in 0.4-
0.8% of the population. The discounted cost per quality
adjusted patient year for surveillance is expensive
($100,000-$500,000). Current recommendations are for
repeat endoscopy every two years. Follow-up of patients
with dysplasia should be more frequent. Surveillance
should stop if patient’s clinical situation would preclude
esophageal resection.
Endoscopic treatments such as thermal ablation,
photodynamic therapy and endoscopic mucosal resection
offer promise to the patient who is not an operative
candidate. They are likely to have fewer complications, but
also lower effectiveness (60-70% loss of cancer/high grade
dysplasia at 2 years follow-up). Hidden cancers or high
grade dysplasia below the epithelial surface may hamper
endoscopic monitoring.

Treatment for H. pylori

Patients with predominant GERD symptoms have a similar
or lower frequency of H. pylori positivity than the general
population. Successful treatment of H. pylori has not been
shown to reduce predominant GERD symptoms. Some
studies have shown decreased PPI effectiveness post
successful H. pylori treatment, but this is still controversial.
One RCT demonstrated that H. pylori eradication leads to
more resilient GERD. Treatment of H. pylori is not
indicated for patients with GERD.
Related National Guidelines
This guideline is consistent with the American College of Gastroenterology’s Updated Guidelines for the Diagnosis and Treatment of Gastroesophageal Reflux Disease (2005) and the VA/DoD Clinical Practice Guideline for the Management of Adults with Gastroesophageal Reflux Disease in Primary Care Practice (2003). (See annotated references.) Strategy for Literature Search
Disclosures
The literature search began with the results of the literature The University of Michigan Health System endorses the search performed through September 2000 for the previous Guidelines of the Association of American Medical version of this guideline. The results of two more recent Colleges and the Standards of the Accreditation Council for Continuing Medical Education that the individuals who American College of Gastroenterology: Updated present educational activities disclose significant Guidelines for the diagnosis and treatment of relationships with commercial companies whose products gastroesophageal reflux disease (2005), literature search or services are discussed. Disclosure of a relationship is not intended to suggest bias in the information presented, but is made to provide readers with information that might be of VA/DOD Clinical Practice Guideline for the potential importance to their evaluation of the information. Management of Adults with Gastroesophageal Reflux Disease in Primary Care Practice (2003), literature search through May 2002. A search of more recent literature was conducted prospectively on Medline from January 2004 through May 2006 using the major keywords of: gastroesophageal reflux disease (or GERD, NERD [non-erosive reflux disease], NEED [non-erosive esophageal disease]), human adults, English language, clinical trials, and guidelines. Terms used for specific topic searches within the major key words included: symptoms (atypical symptoms, heartburn, retrosternal burning sensation precipitated by meals or a recumbent position, hoarseness, laryngitis, sore throat, chronic cough, chest pain, bronchospasm/asthma, dental Annotated References
erosions)nocturnal (or nocturnal breakthrough, night time), endoscopy, pH recording, manometry, provocative testing American College of Gastroenterology: DeVault KR, (Bernstein’s), video esophagography, empiric/therapeutic Castell DO. Updated Guidelines for the Diagnosis and trial to acid suppression, lifestyle measures/treatment Treatment of Gastroesophageal Reflux Disease. American (avoiding fatty foods, chocolate, peppermints, ethanol- Journal of Gastroenterology, 2005; 100:190-200. containing veverages; recumbency for 3 hours after a meal; elevating head of bed; weight loss), antacids, alginic acid A consensus statement outlining the current (gaviscon), carafate, prokinetic agents (cisapride, recommendations by the American College of metoclopramide, bethanechol, dromperidone), H2 receptor Gastroenterology in the diagnosis and treatment of antagonists (nizatidine, ranitidine, famotidine, cimetidine), proton pump inhibitors (omeprazole, lansoprazole, rabeprazole, pantoprazole, esomeprazole), fundoplication American College of Gastroenterology: DeVault KR. (open vs. laproscopy; endoscopic antireflux procedures), Updated Guidelines for the Diagnosis and Treatment of Barretts esophagus (screening, surveillance). Detailed Gastroesophageal Reflux Disease. American Journal of search terms and strategy available upon request. Gastroenterology, 1999; 94(6):1434-1442. This earlier consensus statement includes information The search was conducted in components each keyed to a that is simply referenced in the more recent update specific causal link in a formal problem structure (available upon request). The search was supplemented with very recent information available to expert members of the VA/DoD Clinical Practice Guideline for the Management panel, including abstracts from recent meetings and results of Adults with Gastroesophageal Reflux Disease in Primary of clinical trials. Negative trials were specifically sought. Care Practice. Department of Veterans Affairs and Department of Defense, Draft 8a, March 12, 2003. Conclusions were based on prospective randomized clinical A 60 page report addressing each aspect of diagnosis trials if available, to the exclusion of other data; if randomized controlled trials were not available, observational studies were admitted to consideration. If no Heidelbaugh JJ, Nostrant TT. A Cost-Effective Approach such data were available for a given link in the problem to the Pharmacologic Management of Gastroesophageal formulation, expert opinion was used to estimate effect size. Reflux Disease. Drug Benefit Trends 2004;16:463-471. An in-depth examination of various cost-effective approaches to GERD treatment Heidelbaugh JJ, Nostrant TT. Medical and surgical management of gastroesophageal reflux disease. In: Heidelbaugh JJ (ed). Clinics in Family Practice: Gastroenterology. Philadelphia, PA: Elsevier, September 2004, 6(3):547-568. A systematic review of the literature and evidence-based recommendations for practice in the diagnosis and treatment of GERD. Kahrilas, PJ. Gastroesophageal Reflux Disease. JAMA. 1996;276(12):983-988. A comprehensive review of treatment of GERD with less emphasis on diagnostic modalities. Numans Me, Lau J, deWit NJ, Bonis PA. Short-term treatment with proton-pump inhibitors as a test for gastroesophageal reflux disease: a meta-analysis of diagnostic test characteristics. Annals of Internal Medicine, 2004; 140(7):518-27. A systematic review of this literature, with 15 studies showing the limited sensitivity and specificity of successful short-term treatment with PPI in establishing the diagnosis when GERD is defined by 24-hour pH monitoring. Sridhar, S. Clinical economics review: cost-effectiveness of treatment alternatives for gastro-oesophageal reflux disease. Alim Pharmacol Ther 1996;10:865-873. An economic appraisal reviewing different treatment modalities and their cost-effectiveness. Proton pump inhibitors are considered more cost effective than H2 receptor antagonists in those with documented erosive esophagitis. Vaezi, M. Gastroesophageal reflux disease and the larynx. J Clin Gastroenterol, 2003; 36(3):198-203. Presents the rational for an approach to identifying patients whose laryngeal signs and symptoms are due to GERD.

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Specific clinical issues:

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Microsoft word - particularities pj75sp2 and ipf.doc

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